MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY CATHETERS; CLAMP, CANNULA

Model Number 90 820 1S-10

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

A leak was reported.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.Additional information received on may 30, 2014 informing the leak of the catheter valve required replacement with a new catheter.A quality evaluation was performed on (b)(4) 2014.The sample in closed peel pack has been received and tested: the valve was connected to the tube and filled up with colored water and hung up for 24 hours to monitor the valve tightness.The valves was opened and closed several times.Sample met the tests requirements.History files of the batch manufacturing process have been checked.No nonconformity has been registered during the manufacturing process.No earlier complaint has been received on the batch in question.Based on the investigation findings and information received it has not been possible to determine the root cause of the failure in question.There is no indication of an adverse trend of complaints over the past twelve months for this issue/product.The failure was included in relevant risk management file and associated hazard was evaluated there.Based on investigation results no further action is required.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

• Brand Name: URINARY CATHETERS
• Type of Device: CLAMP, CANNULA
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak, int. assoc dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4088340
• MDR Text Key: 15908421
• Report Number: 3005778470-2014-00053
• Device Sequence Number: 1
• Product Code: FKC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90 820 1S-10
• Device Catalogue Number: 90 820 1S-10
• Device Lot Number: 492977
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1